E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of rotavirus gastroenteritis |
|
E.1.1.1 | Medical condition in easily understood language |
To see if the study vaccine (V260) works to prevent disease (diarrhea and vomiting) caused by the rotavirus germ in infants |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of 3 doses of V260 against rotavirus gastroenteritis caused by naturally-occurring rotavirus (regardless of serotype or disease severity), occurring at least 14 days following the third dose. |
|
E.2.2 | Secondary objectives of the trial |
(1)To assess the safety of V260 with respect to all adverse experiences (AEs) within 30 days after each dose of V260/placebo.
(2) Objective: To evaluate the efficacy of 3 doses of V260 against severe rotavirus
gastroenteritis caused by naturally occurring rotavirus (regardless of serotype)
occurring at least 14 days following the third dose.
(3) Objective: To evaluate the efficacy of V260 against any rotavirus gastroenteritis that
occurs at least 14 days after the first dose in all subjects receiving at least one dose of
V260.
(4) Objective: To evaluate the efficacy of 3 doses of V260 against i) severe and ii) anyseverity
rotavirus gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4, and
G-serotypes that contain P1A[8] (e.g., G9) that occurs at least 14 days following the
third dose.
(5) Objective: To evaluate the impact of V260 on occurrence of any and severe all -
cause gastroenteritis.
(6) Objective: To characterize the antibody responses against OPV antigens. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at time
of administration of the first dose of V260/placebo (Date of Birth is age Day 1).
2. Parent/legal guardian who agrees to participate by giving written informed consent
and is willing and able to comply with study requirements. |
|
E.4 | Principal exclusion criteria |
1. History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery.
2. History of intussusception.
3. Known or suspected impairment of immunological function, including Severe Combined
Immunodeficiency (SCID).
4. Subject with acute diseases, severe chronic diseases, or chronic diseases during the acute
period.
5. Subject with uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological diseases (Contraindications for OPV and DTaP)
6. Known hypersensitivity to any component of the rotavirus vaccine, OPV, and DTaP.
7. Prior administration of any rotavirus vaccines.
8. Fever, with an axillary temperature ≥37.5°C (or equivalent) at the time of vaccination or
within the last 24 hours. Note: Defer the study vaccination visit until complete resolution
of febrile illness.
9. Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal
reflux disease [GERD] may participate in the study as long as the GERD is well controlled with or without medication.
10. Receipt of intramuscular, oral, or intravenous corticosteroid treatment since birth. Note:
Use of topical, ophthalmic, and inhaled steroids are permitted.
11. Subjects residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, organ or bone marrow transplantation, or with those receiving anti-cancer or immunosuppressive chemotherapy including long-term systemic corticosteroids.
12. Prior receipt of a blood transfusion or blood products, including immunoglobulins.
13. Participation in another interventional study within 14 days prior to the first study
vaccination or expected anytime during the study.
14. Receipt of investigational or non-registered product other than study vaccines within 30
days prior to the first study vaccination or planned use during the study period.
15. Additionally, for those participating in Cohort 2 Immunogenicity Subgroup A and
Subgroup B:
a. Inability to obtain blood specimen at randomization visit. NOTE: Re-schedule visit
so that baseline specimen may be obtained prior to the first vaccination.
b. History of polio, diphtheria, tetanus, or pertussis disease.
c. Previous vaccination against diphtheria, tetanus, pertussis or poliomyelitis.
16. Any condition, which, in the opinion of the investigator, ma y interfere with the
evaluation of the study objectives. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy against any severity of rotavirus gastroenteritis |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Efficacy against severe rotavirus gastroenteritis RVGE ≥14 days Postdose 3 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 12 |